July 5, 2019 – shiqiv.com

Talents

The lack of talents has been a well-recognized problem for China’s biotech industry[1]. China lacks seasoned experts with at least 10 years’ industry experience, say insiders. Companies are especially keen on experience in translational medicine, early-stage clinical trials and antibody manufacturing. Start-up biotech firms need experienced managers at every level, from clinical trials to drug manufacturing processes, to help build their companies[2].

This path from multinational drug company to biotech is clearly seen in the bios of many of the more ambitious start-up founders. Returnees with a few years under their belt in China and an ability to effectively navigate the system are far more valuable to employers than new arrivals. It becomes fairly common that multinational biopharma firms are finding themselves battling Chinese biotechnology startups to attract talent^38,[3]. Those startups flush with cash from venture-capital financing are willing to pay top dollar (and upsides with options).

Trials

In terms of conducting trials, a historical lack of clinical research infrastructure in China has led to problems adhering to Good Clinical Practice, the international gold standard for maintaining ethical and quality standards in clinical trials. As an example, nearly all clinical research sites in China are hospitals, as there are no private practices. Because of that, clinical trial participants are treated exactly the same way as regular patients. That’s a problem because study staff — who are regular hospital employees — don’t have experience complying with Good Clinical Practice, putting the trial’s integrity, not to mention patient protection, at risk[4]^,[5].

Meanwhile, the rapid growth of Wuxi AppTex (and its affiliated Wuxi Biologics) has made itself one of the largest CRO/CMO players in the world[6], helping to facilitate drug discovery/development/manufacturing globally.

Launches

As most Chinese biotech startups are still in the r&d stage, only a few were approved recently. The most relevant example here might be the PD-1/PD-L1 space.

CFDA has long been seen as “slow” in terms of new drug approvals. A 2016 discussion quoted that usually a new drug needs 5-10 years for approval[7].

However, for the recent domestic PD-1 drugs for cancer, the approval speed was amazingly fast. Junshi won the first made-in-China PD-1 drug approval by NMPA (formerly CFDA) in December 2018[8]. Ten days later, the second PD-1 drug by Innovent was approved[9]. Each took 284 and 255 days respectively[10].

Two foreign PD-1 drugs, Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo, were approved earlier in 2018. During 18Q3, Keytrude and Opdivo recorded ¥150 and ¥190 million in sales respectively[11].

Junshi started its sales in February 2019 and recorded nearly ¥80 million in the first quarter[12]. Innovent’s PD-1 launched its sales in March 2019 and finished the first quarter with $9.9 million in revenue, both of which are deemed as successful in media reports[13].

[1] https://www.kornferry.com/institute/download/download/id/17053/aid/219

[2] https://www.huamedicine.com/upload/down/5870180130135508.pdf

[3] https://www.ft.com/content/d3a2de0e-6fbb-11e8-92d3-6c13e5c92914

[4] https://www.statnews.com/2018/08/03/china-clinical-trials-infrastructure-transparency/

[5] http://www.appliedclinicaltrialsonline.com/running-clinical-research-china

[6] https://explorebiotech.com/top-cros-usa-contract-research-organization/

[7] http://journal.healthpolicy.cn/html/20160304.htm

[8] https://endpts.com/junshi-wins-the-race-for-first-made-in-china-pd-1-approval-as-execs-reap-394m-ipo-harvest/

[9] https://endpts.com/china-greenlights-second-homegrown-pd-1-in-10-days-as-innovent-celebrates-its-first-drug-ok-with-eli-lilly/

[10] https://www.bjcancer.org/Html/News/Articles/9321.html

[11] https://www.yicai.com/news/100135300.html

[12] https://xueqiu.com/8965749698/125984469